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Updated: Mar 24, 2026
Tumor Treating Field Therapy in Combination with Bevacizumab for the Treatment of Recurrent Glioblastoma
Published on: October 27, 2014
AVAREG: a phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent
Alba A Brandes1, Gaetano Finocchiaro2, Vittorina Zagonel2
1Department of Medical Oncology, Bellaria-Maggiore Hospital, Azienda USL-IRCCS Institute of Neurological Sciences, Bologna, Italy (A.A.B., E.F.); Molecular Neuro-Oncology Unit, IRCCS Foundation Carlo Besta, Milan, Italy (G.F., M.E.); Department of Clinical and Experimental Oncology, Medical Oncology, Veneto Institute of Oncology- IRCCS Padua, Italy (V.Z., G.L.); Department of Medical Oncology, IRCCS San Raffaele, Milan, Italy (M.R.); Oncology Department, Santa Maria Hospital, Terni, Italy (C.C.); Department of Medical Oncology, Regina Elena National Cancer Institute, Rome, Italy (A.F.); E.O. Ospedale Galliera, Genova, Italy (M.C.); Oncology Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy (E.M.); OPIS, Palazzo Aliprandi, Desio MB, Italy (M.M.); Roche S.p.A. Medical Affairs and CO, Monza, Italy (E.P.); Neuroradiology Department, Bellaria-Maggiore Hospital, Azienda USL-IRCCS Institute of Neurological Sciences, Ospedale Bellaria, Bologna, Italy (R.A.); Department of Biomedical and Neuromotor Science, University of Bologna, Section of Anatomic Pathology M. Malpighi-Bellaria Hospital, Bologna, Italy (V.E.) alba.brandes@yahoo.it.
Background:
Few prospective studies have assessed the role of bevacizumab and included a control arm with standard treatments for recurrent glioblastoma. We conducted a noncomparative phase II trial (AVAREG) to examine the efficacy of bevacizumab or fotemustine in this setting.
Methods:
Eligible patients were randomized 2:1 to receive bevacizumab (10 mg/kg every 2 weeks) or fotemustine (75 mg/m(2) on days 1, 8, and 15, then 100 mg/m(2) every 3 weeks after a 35-day interval). The primary endpoint was 6-month overall survival (OS) rate (OS-6). No formal efficacy comparison was made between the treatment arms.
Results:
Ninety-one patients were enrolled (bevacizumab n = 59; fotemustine n = 32). Median age was 57 years (range, 28-78 y), and patients had Eastern Cooperative Oncology Group performance status of 0 (n = 42), 1 (n = 35), or 2 (n = 14). OS-6 rate was 62.1% (95% confidence interval [CI], 48.4-74.5) with bevacizumab and 73.3% (95% CI, 54.1-87.7) with fotemustine. OS-6 rates were lower in bevacizumab-treated patients with MGMT promoter methylated tumors than in those with unmethylated tumors (50% and 85%, respectively), but higher in fotemustine-treated patients (87.5% and 50%, respectively). OS rates at 9 months were 37.9% (95% CI, 25.5-51.6) and 46.7% (95% CI, 28.3-65.7) with bevacizumab and fotemustine, respectively, and median OS was 7.3 months (95% CI, 5.8-9.2) and 8.7 months (95% CI, 6.3-15.4), respectively. Toxicity was as expected with the 2 agents.
Conclusion:
Single-agent bevacizumab may have a role in patients with recurrent glioblastoma.
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